Teva Highlights Growing Respiratory Portfolio at the 2016 ...

IR Contacts: Kevin C. Mannix United States (215) 591-8912

Ran Meir United States (215) 591-3033

Tomer Amitai Israel 972 (3) 926-7656

PR Contacts: Iris Beck Codner Israel 972 (3) 926-7687

Denise Bradley United States (215) 591-8974

Nancy Leone United States (215) 284-0213

Teva Highlights Growing Respiratory Portfolio at the 2016 American College of Allergy, Asthma &

Immunology Annual Scientific Meeting

Data Include Pivotal Results for Two Investigational Treatments for Persistent Asthma and an Oral Presentation on the Healthcare Utilization Impact of Rescue Inhalers with Integrated Dose Counters

JERUSALEM, November 7, 2016 – Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that ten company-sponsored abstracts will be presented at the 2016 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in San Francisco, California on November 10-14, 2016. Data for presentation include results from three Phase III studies and one Phase I study of fluticasone propionate/salmeterol (FS) RespiClick

®, a fixed-dose combination inhaled corticosteroid (ICS) and long-

acting beta agonist (LABA) delivered via Teva’s RespiClick® breath-actuated, multi-dose dry powder

inhaler (MDPI) and for fluticasone propionate (Fp) RespiClick® an ICS monotherapy also delivered via the

RespiClick® device. This will be the first presentation of the Phase III clinical trial results for FS

RespiClick®

and Fp RespiClick®, which are currently under review with the U.S. Food & Drug

Administration for the treatment of adolescent and adult patients with asthma. Abstracts of note include two poster presentations examining the efficacy and safety of Fp RespiClick

® and FS RespiClick

® at

varying doses compared to placebo, and a poster presentation evaluating long-term safety of both products in asthmatic patients. In addition, a retrospective, observational study pertaining to Teva’s rescue medication, ProAir

® HFA

(albuterol sulfate) Inhalation Aerosol from its Health Economics & Outcomes Research division will be presented via oral presentation. The study evaluated the impact of rescue inhalers with integrated dose counters (IDC), specifically ProAir

® HFA, on healthcare utilization among asthmatic patients. Results from

the study show how IDCs significantly contributed to improved outcomes for asthmatic patients while also reducing respiratory-related healthcare utilization, specifically hospitalizations and emergency department visits. “We look forward to presenting new data and analyses for a number of products in our growing respiratory portfolio at the ACAAI Annual Scientific Meeting as we continue our work to help address the needs of people living with respiratory disease,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “When it comes to asthma, there is not a one-size-fits-all approach for treatment. Whether enhancing delivery device technology, enabling patients to track remaining doses in an inhaler with an integrated dose counter, or developing targeted biologic therapies, Teva is committed to developing and delivering therapies that will help patients across the severity spectrum better manage their illness.” The following Teva-sponsored data will be presented at the 2016 ACAAI Annual Meeting:







Fluticasone Propionate/Salmeterol RespiClick® and Fluticasone Propionate RespiClick

®

P148: Long-term Safety of Fluticasone Propionate and Fluticasone Propionate/Salmeterol Multi-dose Dry Powder Inhalers in Asthmatic Patients

o This abstract will be presented during Asthma, Other Lower Airway Disorders on Friday, November 11, 2016 at 3:40 p.m. on Monitor 8

P149: Fluticasone Propionate and Fluticasone Propionate/Salmeterol Multi-dose Dry Powder Inhaler Pharmacokinetics in Patients With Persistent Asthma


P139: Fluticasone Propionate And Fluticasone Propionate/Salmeterol Multi-dose Dry Powder Inhalers Compared With Placebo for Persistent Asthma

o This abstract will be presented during Asthma, Other Lower Airway Disorders on Sunday, November 13, 2016 at 10:15 a.m. on Monitor 7

P142: Fluticasone Propionate and Fluticasone Propionate/Salmeterol Delivered via Multi-dose Dry Powder Inhalers for Persistent Asthma

o This abstract will be presented during Asthma, Other Lower Airway Disorders on Sunday, November 13, 2016 at 12:50 p.m. on Monitor 8

ProAir RespiClick® (albuterol sulfate) Inhalation Powder

P152: Robust Performance of a Multi-dose Dry Powder Inhaler With Albuterol Sulfate Under Various Misuse Scenarios


ProAir

® HFA (albuterol sulfate) Inhalation Aerosol

O024 Healthcare Utilization in Asthma Patients Using Albuterol Hydrofluoroalkane Inhalation Aerosol With/Without an Integrated Dose Counter

o This abstract will be orally presented on November 13, 2016 at 3:15 p.m. in Room 3024 Beclomethasone dipropionate HFA BAI

P150: Evaluation of Beclomethasone Dipropionate (80 and 160 mcg/day) Delivered via Breath Actuated Inhaler for Persistent Asthma


P143: Beclomethasone Dipropionate Pharmacokinetics Delivered by Breath Actuated Inhaler and Metered Dose Inhaler in Healthy Subjects


CINQAIR

®/CINQAERO

® (reslizumab) Injection

P154: Indirect Comparison of Exacerbation Rates Among Patients Treated with Reslizumab Compared to Omalizumab and Mepolizumab

o This abstract will be presented during Asthma, Other Lower Airway Disorders on Friday, November 11, 2016 at 4:40pm on Monitor 8

P155: Higher binding affinity and in vitro potency of reslizumab for interleukin-5 compared with mepolizumab







o This abstract will be presented during Asthma, Other Lower Airway Disorders on

Saturday, November 12, 2016 at 10:50 am on Monitor 8

About Teva Respiratory Teva Respiratory develops and delivers high-quality treatment options for respiratory conditions, including asthma, COPD and allergic rhinitis. The Teva Respiratory portfolio is centered on optimizing respiratory treatment for patients and healthcare providers through the development of novel delivery systems and therapies that help address unmet needs. The company’s respiratory pipeline and clinical trial program are based on drug molecules delivered in proprietary dry powder formulations and breath-actuated device technologies, as well as a targeted biologic treatment for severe asthma. Through research and clinical development, Teva Respiratory continually works to expand, strengthen and build upon its treatment portfolio to positively impact the lives of the millions of patients living with respiratory disease. About CINQAIR


CINQAIR (reslizumab) Injection is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype. Limitations of Use: CINQAIR is not indicated for:

treatment of other eosinophilic conditions

relief of acute bronchospasm or status asthmaticus IMPORTANT SAFETY INFORMATION WARNING: ANAPHYLAXIS

Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR.

Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Discontinue CINQAIR immediately if the patient experiences signs or symptoms of anaphylaxis.

CONTRAINDICATIONS

CINQAIR is contraindicated in patients who have known hypersensitivity to reslizumab or any of its excipients.

WARNINGS AND PRECAUTIONS

Acute Asthma Symptoms or Deteriorating Disease: CINQAIR should not be used to treat acute asthma symptoms or acute exacerbations. Do not use CINQAIR to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with CINQAIR.

Malignancy: In placebo-controlled clinical studies, 6/1028 (0.6%) patients receiving 3 mg/kg CINQAIR had at least 1 malignant neoplasm reported compared to 2/730 (0.3%) patients in the placebo group. The observed malignancies in CINQAIR-treated patients were diverse in nature and







without clustering of any particular tissue type. The majority of malignancies were diagnosed within less than six months of exposure to CINQAIR.

Reduction of Corticosteroid Dosage: No clinical studies have been conducted to assess reduction of maintenance corticosteroid dosages following administration of CINQAIR. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with CINQAIR. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection: Eosinophils may be involved in the immunological response to some helminth infections. Treat patients with pre-existing helminth infections before initiating CINQAIR. If patients become infected while receiving treatment with CINQAIR and do not respond to anti-helminth treatment, discontinue treatment with CINQAIR until infection resolves.

ADVERSE REACTIONS

Adverse reactions that occurred at ≥2% incidence and more commonly than in the placebo group included 1 event: oropharyngeal pain (2.6% vs. 2.2%).

Elevated baseline creatine phosphokinase (CPK) was more frequent in patients randomized to CINQAIR (14%) versus placebo (9%). Transient CPK elevations in patients with normal baseline CPK values were observed more frequently with CINQAIR (20%) versus placebo (18%) during routine laboratory assessments.

Myalgia was reported in 1% (10/1028) of patients in the CINQAIR 3 mg/kg group compared to 0.5% (4/730) of patients in the placebo group.

Immunogenicity: In placebo-controlled studies, a treatment-emergent anti-reslizumab antibody response developed in 53/983 (5.4%) of CINQAIR-treated patients (3 mg/kg). The antibody responses were of low titer and often transient. There was no detectable impact of the antibodies on the clinical pharmacokinetics, pharmacodynamics, clinical efficacy, and safety of CINQAIR.

Please click here for full Prescribing Information About ProAir

® RespiClick (albuterol sulfate) Inhalation Powder

ProAir® RespiClick (albuterol sulfate) Inhalation Powder is indicated in patients 4 years of age and older

for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. IMPORTANT SAFETY INFORMATION

ProAir RespiClick® (albuterol sulfate) Inhalation Powder is contraindicated in patients with

hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose

http://www.cinqair.com/pdf/PrescribingInformation.pdf







ProAir RespiClick® can produce paradoxical bronchospasm that may be life-threatening.

Discontinue ProAir RespiClick® and institute alternative therapy if paradoxical bronchospasm

occurs

Need for more doses of ProAir RespiClick® than usual may be a marker of acute or chronic

deterioration of asthma and requires reevaluation of treatment

ProAir RespiClick® alone may not be adequate to control asthma in many patients. Early

consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids

ProAir RespiClick

®, like other beta-adrenergic agonists, can produce clinically significant

cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued

ProAir RespiClick®, as with all sympathomimetic amines, should be used with caution in patients

with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), convulsive disorders, hyperthyroidism, and diabetes

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. Do not exceed the recommended dose

Immediate hypersensitivity reactions may occur. Discontinue ProAir RespiClick® immediately

ProAir RespiClick® may produce significant hypokalemia in some patients, which has the

potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation

Potential drug interactions can occur with beta-blockers, diuretics, digoxin, or monoamine oxidase inhibitors, and tricyclic antidepressants

In controlled studies of ProAir RespiClick® in patients 12 years of age and older, adverse events

that occurred at an incidence rate of at least 1% and greater than placebo included back pain (2% vs 1%), pain (2% vs <1%), gastroenteritis viral (1% vs <1%), sinus headache (1% vs <1%), and urinary tract infection (1% vs <1%)

In controlled studies of ProAir RespiClick® in patients 4 to 11 years of age, adverse events that

occurred at an incidence rate of at least 2% and greater than placebo included nasopharyngitis (2% vs 1%), oropharyngeal pain (2% vs 1%), and vomiting (3% vs 1%)

Please click here for Full Prescribing Information About ProAir


ProAir® HFA (albuterol sulfate) Inhalation Aerosol is indicated in patients 4 years of age and older for the

treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

IMPORTANT SAFETY INFORMATION

Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life-threatening. It

should be recognized that paradoxical bronchospasm, when associated with inhaled

formulations, frequently occurs with the first use of a new canister

Fatalities have been reported in association with excessive use of inhaled sympathomimetic

drugs in patients with asthma

ProAir HFA, as with all sympathomimetic amines, should be used with caution in patients with

cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and

hypertension), convulsive disorders, hyperthyroidism, and diabetes

http://myproair.com/pdf/Full_Prescribing_And_Patient_Information.pdf







Potential drug interactions can occur with beta-blockers, diuretics, digoxin, or monoamine oxidase

inhibitors, and tricyclic antidepressants.

Do not exceed the recommended dose

Adverse events, which occurred at an incidence rate of at least 3% with ProAir HFA, include

headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis Please click here for full Prescribing Information About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com. Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our specialty products, especially Copaxone® (which faces competition from orally-administered alternatives and a generic version); our ability to integrate Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”) and to realize the anticipated benefits of the acquisition (and the timing of realizing such benefits); the fact that following the consummation of the Actavis Generics acquisition, we are dependent to a much larger extent than previously on our generic pharmaceutical business; potential restrictions on our ability to engage in additional transactions or incur additional indebtedness as a result of the substantial amount of debt incurred to finance the Actavis Generics acquisition; the fact that for a period of time following the Actavis Generics acquisition, we will have significantly less cash on hand than previously, which could adversely affect our ability to grow; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from investments in our pipeline of specialty and other products; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; governmental investigations into sales and marketing practices, particularly for our

http://www.proair.com/respiclick/library/docs/PI.pdf

http://www.tevapharm.com/







specialty pharmaceutical products; adverse effects of political or economic instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; the impact of continuing consolidation of our distributors and customers; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; our potential exposure to product liability claims that are not covered by insurance; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; significant impairment charges relating to intangible assets, goodwill and property, plant and equipment; the effects of increased leverage and our resulting reliance on access to the capital markets; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2015 and in our other filings with the U.S. Securities and Exchange Commission (the "SEC"). Forward-looking statements speak only as of the date on which they are made and we assume no obligation to update or revise any forward-looking statements or other information, whether as a result of new information, future events or otherwise.

# # #







' של הקולג 2016 -להשנתי המדעי הולך וגדל בתחום מערכת הנשימה בכנס פורטפוליו טבע מציגה אסטמה ואימונולוגיה, האמריקאי לאלרגיה

על ההשפעה של פה-ומצגת בעל, יוניים באסטמה מתמשכתשני טיפולים ניס שלהנתונים שיוצגו כוללים תוצאות עיקריות במשאפי חירום עם מונה משולב במונה מינונים שימוש

הודיעה היום כי עשרה תקצירי ( TASE :TEVA-ו NYSE)מ "טבע תעשיות פרמצבטיות בע - 2016בנובמבר 7, ירושלים

אסטמה ואימונולוגיה , האמריקאי לאלרגיה' של הקולג 2016מאמרים ממחקרים במימון החברה יוצגו בכנס המדעי השנתי (ACAAI )2016, לנובמבר 14 - 10-ב, קליפורניה, שייערך בסן פרנסיסקו.

Fluticasone Propionate/Salmeterolעל 1וממחקר אחד שלב 3הנתונים שיוצגו כוללים תוצאות משלושה מחקרי שלב (FS )RespiClick

®הניתנים (, LABA)טווח -אגוניסט ארוך-ובטא( ICS)שילוב מינונים קבועים של קורטיקוסטרואיד בשאיפה ,

RespiClickבאמצעות ®

Fluticasoneועל ; המופעל באמצעות נשימה( MDPI)מינון -שהוא משאף אבקה יבשה רב, של טבע Propionate (Fp) RespiClick

®RespiClickשניתן גם הוא באמצעות משאף , יחיד ICSטיפול ,

®זו תהיה ההצגה .

FS RespiClickבור ע 3הראשונה של תוצאות המחקרים הקליניים שלב ®

Fp RespiClick-ו ®

שנמצאים בימים אלה , נתונים , בין היתר. לטיפול בבני נוער ומבוגרים החולים באסטמה( FDA)בבדיקה של מנהל המזון והתרופות האמריקאי

Fp RespiClickמתקצירים עיקריים יוצגו בשתי מצגות פוסטרים המתארות את היעילות והבטיחות של ®

FS RespiClick-ו ®

ובמצגת פוסטר המתארת הערכה של הבטיחות לאורך זמן של שני המוצרים בטיפול בחולי , במינונים שונים בהשוואה לפלצבו

.אסטמה

, פה שבה יוצגו נתונים אבחנתיים ממחקר רטרוספקטיבי הנוגע לתרופה למצבי חירום של טבע-בנוסף תתקיים מצגת בעלProAirמשאף התרסיס

® HFA (Albuterol Sulfate ,) שתועבר על ידי חטיבתHealth Economics & Outcomes

Research המחקר העריך את השפעת השימוש במשאפים למצבי חירום עם מונה משולב של מינון מדוד . של החברה(IDC ,) ובאופן ספציפי במשאףProAir

® HFA ,אות כיצד תוצאות המחקר מר. על צריכת שירותי בריאות בקרב חולי אסטמה

ובמקביל הפחיתו את הצורך , משאפים עם מינון מדוד תרמו באופן משמעותי לתוצאות משופרות במצבם של חולי אסטמהספציפית את הצורך באשפוזים ובביקורים בחדרי מיון ובמוקדי , בשימוש בשירותי בריאות הקשורים לאירועים נשימתיים

.רפואה דחופה נתונים חדשים וניתוחי נתונים של מספר מוצרים בפורטפוליו ההולך וגדל של מוצרים שלנו אנחנו שמחים להזדמנות להציג "

כחלק מהמשך המאמצים שלנו לעזור לאנשים המתמודדים עם מחלות , ACAAIלמערכת הנשימה בכנס המדעי השנתי של . ת הנשימה של טבעמחקר ופיתוח גלובלי בתחום מערכ, ל בכיר"סמנכ, ר טושאר שאה"אמר ד", של מערכת הנשימה

טבע משפרת את טכנולוגיית . אי אפשר לנקוט גישה טיפולית של פתרון אחד שמתאים לכולם, כשמדובר באסטמה"וממשיכה , מאפשרת לחולים לעקוב אחרי כמות המינונים שנותרה במשאף עם מונה מינונים משולב, המכשירים למתן תרופות

לק מהמחויבות שלנו לפיתוח והצעת טיפולים שיעזרו לחולים בכל דרגות החומרה הכל כח -לפתח טיפולים ביולוגיים ממוקדים ".של המחלה לנהל את הטיפול בצורה טובה יותר

:ACAAI-של ה 2016הנתונים הבאים ממחקרים במימון טבע יוצגו בכנס השנתי

Fluticasone Propionate/Salmeterol RespiClick

® and Fluticasone Propionate RespiClick

®

P148: Long-term Safety of Fluticasone Propionate and Fluticasone Propionate/Salmeterol Multi-dose Dry Powder Inhalers in Asthmatic Patients


P149: Fluticasone Propionate and Fluticasone Propionate/Salmeterol Multi-dose Dry Powder Inhaler Pharmacokinetics in Patients With Persistent Asthma








P139: Fluticasone Propionate And Fluticasone Propionate/Salmeterol Multi-dose Dry Powder Inhalers Compared With Placebo for Persistent Asthma

o This abstract will be presented during Asthma, Other Lower Airway Disorders on Sunday, November 13, 2016 at 10:15 a.m. on Monitor 7

P142: Fluticasone Propionate and Fluticasone Propionate/Salmeterol Delivered via Multi-dose Dry Powder Inhalers for Persistent Asthma


ProAir RespiClick® (albuterol sulfate) Inhalation Powder

P152: Robust Performance of a Multi-dose Dry Powder Inhaler With Albuterol Sulfate Under Various Misuse Scenarios


ProAir


O024 Healthcare Utilization in Asthma Patients Using Albuterol Hydrofluoroalkane Inhalation Aerosol With/Without an Integrated Dose Counter

o This abstract will be orally presented on November 13, 2016 at 3:15 p.m. in Room 3024 Beclomethasone dipropionate HFA BAI

P150: Evaluation of Beclomethasone Dipropionate (80 and 160 mcg/day) Delivered via Breath Actuated Inhaler for Persistent Asthma


P143: Beclomethasone Dipropionate Pharmacokinetics Delivered by Breath Actuated Inhaler and Metered Dose Inhaler in Healthy Subjects


CINQAIR

®/CINQAERO


P154: Indirect Comparison of Exacerbation Rates Among Patients Treated with Reslizumab Compared to Omalizumab and Mepolizumab

o This abstract will be presented during Asthma, Other Lower Airway Disorders on Friday, November 11, 2016 at 4:40pm on Monitor 8

P155: Higher binding affinity and in vitro potency of reslizumab for interleukin-5 compared with mepolizumab

o This abstract will be presented during Asthma, Other Lower Airway Disorders on

Saturday, November 12, 2016 at 10:50 am on Monitor 8

אודות תחום הנשימה בטבע

מחלת ריאות , תחום הנשימה בטבע מפתח ומספק אפשרויות טיפול איכותיות לתופעות נשימתיות ובהן אסתמההפורטפוליו של תחום הנשימה בטבע ממוקד בהשגת אופטימיזציה עבור טיפולי . חסימתית כרונית ונזלת אלרגית







ולים חדשניים בכדי לענות על נשימה למטופלים וספקי שירותי בריאות באמצעות פיתוח דרכי מתן תרופה וטיפצבר המוצרים ותכניות הפיתוח הקליני של תחום הנשימה בטבע מתבססים על מולקולות . צרכים ללא מענה

-המועברות למטופל באמצעות טכנולוגיות תכשירים קנייניות של פורמולציות אבקה יבשה ומשאפים מופעליבאמצעות מחקר . אסתמה הנשלטת באופן בלתי מספקכמו גם טיפולים ביולוגיים ממוקדים לטיפול ב, נשימה

לחזק ולבנות על הפורטפוליו הטיפולי שלו בכדי להשפיע , תחום הנשימה בטבע ממשיך להרחיב, ופיתוח קליני . לחיוב על חייהם של מיליוני מטופלים החיים עם מחלות נשימה

בהזרקה CINQAIR® (reslizumab)אודות

CINQAIR® (Reslizumab )5נוגדן חד שבטי נגד אינטרלוקין הוא (IgG4 kappa ) המיועד לשימוש כטיפול

.עם פנוטיפ אאוזינופילי, ומעלה הסובלים מאסטמה חריפה 18תחזוקתי משלים בחולים בני

מותווה לשימוש במצבים אחרים עם רמת אאוזינופילים גבוהה או להקלה על אינו ®CINQAIR: הגבלות שימוש

(.Status Asthmaticus)ו בעיצומו של התקף אסטמה חמור ברונכוספאזם חריף א


WARNING: ANAPHYLAXIS

Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR.

Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Discontinue CINQAIR immediately if the patient experiences signs or symptoms of anaphylaxis.

CONTRAINDICATIONS

CINQAIR is contraindicated in patients who have known hypersensitivity to reslizumab or any of its excipients.

WARNINGS AND PRECAUTIONS

Acute Asthma Symptoms or Deteriorating Disease: CINQAIR should not be used to treat acute asthma symptoms or acute exacerbations. Do not use CINQAIR to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with CINQAIR.

Malignancy: In placebo-controlled clinical studies, 6/1028 (0.6%) patients receiving 3 mg/kg CINQAIR had at least 1 malignant neoplasm reported compared to 2/730 (0.3%) patients in the placebo group. The observed malignancies in CINQAIR-treated patients were diverse in nature and







without clustering of any particular tissue type. The majority of malignancies were diagnosed within less than six months of exposure to CINQAIR.

Reduction of Corticosteroid Dosage: No clinical studies have been conducted to assess reduction of maintenance corticosteroid dosages following administration of CINQAIR. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with CINQAIR. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection: Eosinophils may be involved in the immunological response to some helminth infections. Treat patients with pre-existing helminth infections before initiating CINQAIR. If patients become infected while receiving treatment with CINQAIR and do not respond to anti-helminth treatment, discontinue treatment with CINQAIR until infection resolves.

ADVERSE REACTIONS

Adverse reactions that occurred at ≥2% incidence and more commonly than in the placebo group included 1 event: oropharyngeal pain (2.6% vs. 2.2%).

Elevated baseline creatine phosphokinase (CPK) was more frequent in patients randomized to CINQAIR (14%) versus placebo (9%). Transient CPK elevations in patients with normal baseline CPK values were observed more frequently with CINQAIR (20%) versus placebo (18%) during routine laboratory assessments.

Myalgia was reported in 1% (10/1028) of patients in the CINQAIR 3 mg/kg group compared to 0.5% (4/730) of patients in the placebo group.

Immunogenicity: In placebo-controlled studies, a treatment-emergent anti-reslizumab antibody response developed in 53/983 (5.4%) of CINQAIR-treated patients (3 mg/kg). The antibody responses were of low titer and often transient. There was no detectable impact of the antibodies on the clinical pharmacokinetics, pharmacodynamics, clinical efficacy, and safety of CINQAIR.

Please click here for full Prescribing Information

ProAir® RespiClick (Albuterol Sulfate)אבקת האינהלציה אודות

היא לטיפול או למניעה של ProAir® RespiClick (Albuterol Sulfate )ההתוויה של אבקת האינהלציה

ברונכוספאזם המתרחש במחלת ריאות חסימתית הפיכה ולמניעת ברונכוספאזם בעקבות מאמץ בקרב חולים בגיל

.ארבע ומעלה


ProAir RespiClick® (albuterol sulfate) Inhalation Powder is contraindicated in patients with

hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases

http://www.cinqair.com/pdf/PrescribingInformation.pdf







of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose

ProAir RespiClick® can produce paradoxical bronchospasm that may be life-threatening.

Discontinue ProAir RespiClick® and institute alternative therapy if paradoxical bronchospasm

occurs

Need for more doses of ProAir RespiClick® than usual may be a marker of acute or chronic

deterioration of asthma and requires reevaluation of treatment

ProAir RespiClick® alone may not be adequate to control asthma in many patients. Early

consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids

ProAir RespiClick

®, like other beta-adrenergic agonists, can produce clinically significant

cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued

ProAir RespiClick®, as with all sympathomimetic amines, should be used with caution in patients

with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), convulsive disorders, hyperthyroidism, and diabetes

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. Do not exceed the recommended dose

Immediate hypersensitivity reactions may occur. Discontinue ProAir RespiClick® immediately

ProAir RespiClick® may produce significant hypokalemia in some patients, which has the

potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation

Potential drug interactions can occur with beta-blockers, diuretics, digoxin, or monoamine oxidase inhibitors, and tricyclic antidepressants

In controlled studies of ProAir RespiClick® in patients 12 years of age and older, adverse events

that occurred at an incidence rate of at least 1% and greater than placebo included back pain (2% vs 1%), pain (2% vs <1%), gastroenteritis viral (1% vs <1%), sinus headache (1% vs <1%), and urinary tract infection (1% vs <1%)

In controlled studies of ProAir RespiClick® in patients 4 to 11 years of age, adverse events that

occurred at an incidence rate of at least 2% and greater than placebo included nasopharyngitis (2% vs 1%), oropharyngeal pain (2% vs 1%), and vomiting (3% vs 1%)

Please click here for Full Prescribing Information

ProAir תרסיס השאיפהאודות ® HFA (Albuterol Sulfate)

ProAirהאינהלציה ההתוויה של אבקת ® HFA (Albuterol Sulfate ) היא לטיפול או למניעה של ברונכוספאזם

.המתרחש במחלת ריאות חסימתית הפיכה ולמניעת ברונכוספאזם בעקבות מאמץ בקרב חולים בגיל ארבע ומעלה


Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life-threatening. It

should be recognized that paradoxical bronchospasm, when associated with inhaled

formulations, frequently occurs with the first use of a new canister

http://myproair.com/pdf/Full_Prescribing_And_Patient_Information.pdf







Fatalities have been reported in association with excessive use of inhaled sympathomimetic

drugs in patients with asthma

ProAir HFA, as with all sympathomimetic amines, should be used with caution in patients with

cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and

hypertension), convulsive disorders, hyperthyroidism, and diabetes

Potential drug interactions can occur with beta-blockers, diuretics, digoxin, or monoamine oxidase

inhibitors, and tricyclic antidepressants.

Do not exceed the recommended dose

Adverse events, which occurred at an incidence rate of at least 3% with ProAir HFA, include

headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis Please click here for full Prescribing Information

אודות טבע

היא חברת תרופות גלובלית המספקת פתרונות בריאות ( NYSE & TASE: TEVA)מ "טבע תעשיות פרמצבטיות בע

היא יצרנית , שבסיסה בישראל, טבע. מיליוני מטופלים מדי יוםהמשמשים מטופל באיכות גבוהה -ממוקדי

מולקולות לייצר מגוון רחב 1,800-צבר מוצריה הכולל יותר מהממנפת את , התרופות הגנריות הגדולה בעולם

טבע הינה חברה מובילה בטיפולים , בתחום התרופות הייחודיות. של מוצרים גנריים ברוב התחומים הטיפוליים

והיא מחזיקה גם צבר מוצרים חזק בתחום מחלות , כולל כאב, למחלות מערכת העצבים המרכזית חדשניים

ת את כישוריה בתחום התרופות הגנריות ובתחום התרופות הייחודיות בחטיבת המחקר טבע משלב. הנשימה

במטרה ליצור דרכים חדשות לענות על צרכי המטופלים וזאת על ידי שילוב יכולות , והפיתוח הגלובלית שלה

-ב הסתכמו 2015הכנסות טבע בשנת . שירותים וטכנולוגיות, בתחום פיתוח תרופות יחד עם פיתוח תכשירים

. www.tevapharm.comבקרו באתר , למידע נוסף על החברה. מיליארד$ 19.7

Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our specialty products, especially Copaxone® (which faces competition from orally-administered alternatives and a generic version); our ability to integrate Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”) and to realize the anticipated benefits of the acquisition (and the timing of realizing such benefits); the fact that following the consummation of the Actavis Generics acquisition, we are dependent to a much larger extent than previously on our generic pharmaceutical business; potential restrictions on our ability to engage in additional transactions or incur additional indebtedness as a result of the substantial amount of debt incurred to finance the Actavis Generics acquisition; the fact that for a period of time following the Actavis Generics acquisition, we will have significantly less cash on hand than previously, which could adversely affect our ability to grow; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from investments in our pipeline of specialty and other products; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our

http://www.proair.com/respiclick/library/docs/PI.pdf

http://www.tevapharm.com/







reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; adverse effects of political or economic instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; the impact of continuing consolidation of our distributors and customers; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; our potential exposure to product liability claims that are not covered by insurance; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; significant impairment charges relating to intangible assets, goodwill and property, plant and equipment; the effects of increased leverage and our resulting reliance on access to the capital markets; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2015 and in our other filings with the U.S. Securities and Exchange Commission (the "SEC"). Forward-looking statements speak only as of the date on which they are made and we assume no obligation to update or revise any forward-looking statements or other information, whether as a result of new information, future events or otherwise.

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